Mycophenolate: OB-GYN Contraception Counseling Referral

Current as of 6/1/2013. This document may not be part of the latest approved REMS. OB/GYN CONTRACEPTION COUNSELING LETTER Reference ID: 3194413 Current as of 6/1/2013. This document may not be part of the latest approved REMS. Letter to Ob/Gyn Contraception Counseling ((Date)) ((Recipient’s Name)) ((Recipient’s Address 1)) ((Recipient’s Address 2)) ((City, State, ZIP)) In reference to: My patient ((Patient’s Name)) Reason for the referral: Contraception counseling Dear Dr ((Recipient’s Last Name)): I am writing to you in reference to the above-named patient who is under my care for ((diagnosis)) and ((insert drug information such as drug name, when patient will begin taking the drug, if treatment has already begun, etc)). This medication contains mycophenolate, which is associated with an increased risk of first trimester pregnancy loss and congenital malformations. It is important that this patient receive contraception counseling about methods that are acceptable for use while taking mycophenolate. Prescribers of mycophenolate participate in the FDA-mandated Mycophenolate REMS (Risk Evaluation and Mitigation Strategy) to ensure that the benefits of mycophenolate outweigh the risks. The following table lists the forms of contraception that are acceptable for use during treatment with mycophenolate. Acceptable Contraception Methods for Females of Reproductive Potential Guide your patients to choose from the following birth control options: Option 1 Intrauterine devices (IUDs) Tubal sterilization Methods to Use Patient’s partner had a vasectomy Alone OR Option 2 Hormone Methods Barrier Methods choose 1 choose 1 Choose One Estrogen and Progesterone Diaphragm with spermicide Hormone Method Oral contraceptive pill Cervical cap with spermicide AND One Barrier Transdermal patch Contraceptive sponge Method Vaginal ring Male condom AND Progesterone-only Female condom Injection Implant OR Option 3 Barrier Methods Barrier Methods choose 1 choose 1 Choose One Diaphragm with spermicide Male condom Barrier Method Cervical cap with spermicide Female condom From Each AND Column (must Contraceptive sponge choose two methods) Reference ID: 3194413 Current as of 6/1/2013. This document may not be part of the latest approved REMS. Patients should be aware that mycophenolate reduces blood levels of the hormones in the oral contraceptive pill and could reduce its effectiveness. An additional barrier method must be used with any hormonal contraceptives. Patients should also be counseled on the availability of emergency contraception. Unless patients choose not to have sexual intercourse with a man at any time (abstinence), they should be instructed to use acceptable birth control during the entire treatment with mycophenolate and for 6 weeks after they stop taking mycophenolate. You can find more information about Mycophenolate REMS, including the roles and responsibilities of patients and prescribers of mycophenolate, at www.MycophenolateREMS.com. The site provides educational materials, as well as access to full Prescribing Information, Important Safety Information and Medication Guides for mycophenolate-containing products. Please call me at ((Signatory’s phone)) at your earliest convenience. Thank you for your cooperation. Sincerely, ((Signatory’s Name)) ((Signatory’s Practice)) CC10/11 Reference ID: 3194413.

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